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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03240523




Registration number
NCT03240523
Ethics application status
Date submitted
21/07/2017
Date registered
7/08/2017
Date last updated
18/10/2024

Titles & IDs
Public title
A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Scientific title
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Secondary ID [1] 0 0
2016-002855-48
Secondary ID [2] 0 0
15789
Universal Trial Number (UTN)
Trial acronym
ASTEROID 5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroids 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vilaprisan (BAY1002670)

Experimental: Group A1: Vilaprisan (3/1 regimen) - Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode

Experimental: Group A2: Vilaprisan (6/2 regimen) - Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes

Experimental: Group A3/B (3/2 regimen) - Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes

With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.


Treatment: Drugs: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Amenorrhea (yes/no)
Timepoint [1] 0 0
At 3 months (at the end of treatment perid 1)
Secondary outcome [1] 0 0
Total volume of menstrual blood loss
Timepoint [1] 0 0
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary outcome [2] 0 0
Number of bleeding days
Timepoint [2] 0 0
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary outcome [3] 0 0
Amenorrhea (yes/no)
Timepoint [3] 0 0
At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Secondary outcome [4] 0 0
Absence of bleeding (spotting allowed)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Time to onset of controlled bleeding
Timepoint [5] 0 0
Quarterly up to 24 months
Secondary outcome [6] 0 0
HMB (Heavy Menstrual Bleeding) responder rate
Timepoint [6] 0 0
By treatment period up to 24 months
Secondary outcome [7] 0 0
Percent change in volume of largest fibroid compared to baseline
Timepoint [7] 0 0
At baseline, at 12 months and at 24 months
Secondary outcome [8] 0 0
Endometrial histology
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Endometrial thickness
Timepoint [9] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
* Women, 18 years or older at the time of Visit 1
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
* Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
* Use of an acceptable non-hormonal method of contraception
* An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drugs
* Hemoglobin values =6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values =10.9 g/dL will be recommended to use iron supplementation)
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including
* Abuse of alcohol, drugs, or medicines (eg: laxatives)
* Undiagnosed abnormal genital bleeding
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2021
Sample size
Target
Accrual to date
Final
766
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Wyong Complex - Kanwal
Recruitment hospital [3] 0 0
Women's Health and Research Institute of Australia-WHRIA - Sydney
Recruitment hospital [4] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
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Austria
State/province [2] 0 0
Vorarlberg
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Austria
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Wien
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Belgium
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Oost-Vlaanderen
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Belgium
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Bruxelles - Brussel
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Belgium
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La Louviere
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Belgium
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Liege
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Belgium
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Tienen
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Bulgaria
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Blagoevgrad
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Bulgaria
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Dobrich
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Bulgaria
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Dupnitsa
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Bulgaria
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Panagyurishte
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Varna
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Canada
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British Columbia
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Newfoundland and Labrador
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Ontario
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Quebec
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Czechia
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Brno
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Olomouc
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Pisek
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Czechia
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Plzen
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Tabor
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Hvidovre
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Odense C
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Finland
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Helsinki
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Kotka
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Kuopio
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Oulu
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Nordrhein-Westfalen
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Sachsen-Anhalt
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Baja
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Uppsala
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Kaohsiung
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Taichung
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Taipei
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Taoyuan
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Hampshire
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
Trial website
https://clinicaltrials.gov/study/NCT03240523
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03240523